Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OXYCODONE HYDROCHLORIDE
MUNDIPHARMA PHARMACEUTICALS SDN. BHD.
OXYCODONE HYDROCHLORIDE
30tablet Tablets; 20tablet Tablets
Purdue Pharmaceuticals L.P.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ OXYCONTIN ® CONTROLLED-RELEASE TABLETS Oxycodone hydrochloride (10mg, 20mg, 40mg, 80mg) 1 WHAT IS IN THIS LEAFLET 1. What OxyContin® is used for 2. How OxyContin®works 3. Before you use OxyContin® 4. How to use OxyContin® 5. While you are taking it 6. Side effects 7. Storage and Disposal of OxyContin® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT OXYCONTIN® IS USED FOR These tablets have been prescribed for you by your doctor to relieve moderate to severe pain that require daily around- the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioids medicines do not treat your pain well enough or you cannot tolerate them. A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. Not for use to treat pain that is not around-the-clock. _ _ HOW OXYCONTIN® WORKS Oxycodone is a full opioid agonist with no antagonist properties. It has an affinity for kappa, mu and delta opiate receptors in the brain and spinal cord. Oxycodone is similar to morphine in its action. The therapeutic effect is mainly analgesic, antianxiety and sedative. BEFORE YOU TAKE OXYCONTIN® _-When you must not use it _ Do not take OxyContin ® tablets if - are allergic (hypersensitive) to oxycodone - severe asthma, trouble breathing or other lung problems - a bowel blockage or have narrowing of the stomach or intestines _ _ _-Before you start take it _ Before treatment with these tablets tell your doctor or pharmacist if you: - have low blood pressure (hypotension) including from having low blood volume - have head injury - have liver or kidney problem - have adrenal gland problems, such as Addison’s disease - have convulsions or seizures - have alcoholism - have hallunications Прочитать полный документ
PRODUCT INFORMATION _OXYCONTIN_ ® CONTROLLED RELEASE TABLETS (10 MG, 20 MG, 40 MG, 80 MG) CAUTION: THIS PREPARATION MAY BE HABIT FORMING ON PROLONGED USE NAME OF THE MEDICINE Non-proprietary name :Oxycodone hydrochloride Chemical name :4,5 -epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride CAS No. :124-90-3 Molecular formula (anhydrous form): C 18 H 21 NO 4 .HCl Molecular weight (anhydrous form): 351.83 Molecular formula (monohydrate form): C 18 H 21 NO 4 .HCl.H 2 0 Molecular weight (monohydrate form): 369.84 Structural formula (anhydrous form): DESCRIPTION Oxycodone hydrochloride is a white, crystalline, odourless powder readily soluble in water, sparingly soluble in ethanol and nearly insoluble in ether. _OxyContin_ tablets are modified release tablets designed to provide delivery of oxycodone over 12 hours. _OxyContin_ 10 mg, 20 mg, 40 mg, and 80 mg tablets have been reformulated, and comprise a matrix formulation with a hydrogelling property (i.e. particles or whole tablets become highly viscous (gel-like) in water), intended to be crush-deterrent and to reduce the rapid release of oxycodone upon accidental or intentional misuse. The tablets have been heat-treated to increase the mechanical strength of the tablet. The physical properties of the reformulated _OxyContin_ tablets were examined following an extensive battery of physical manipulations. Beyond demonstrating that the reformulated _OxyContin_ tablets are harder to crush than another controlled release oxycodone formulation, testing over the range of the reformulated _OxyContin_ tablets fragment sizes showed that some of the controlled release properties were still retained. Hydrogelling properties continued to be demonstrated. For Hospital Use Only The inactive ingredients in the reformulated _OxyContin_ 10 to 80 mg tablets are: polyethylene oxide, butylated hydroxytoluene (BHT) and magnesium stearate. The tablets’ film coating also contain: Opadry Y-5-18024-A White (US version) (ARPING No. 3548) (10mg), Opadry YS- 1- 14518-A P Прочитать полный документ